FDA 510(k)

무균 Nitrile 검사 장갑 2.8 블루 색상, 비 무균, 화학 치료약, 페닌시르트릿, 그리고 선택된 다른 약물과 사용 시험을 통과한 장갑

K-번호: K233598 · 2024-01-26

신청자Anhui Intco Medical Products Co., Ltd.

결정일2024-01-26

제품 코드LZA

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Intco Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K233598. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs?

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Anhui Intco Medical Products Co., Ltd.. The 510(k) number is K233598.

When did Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs receive FDA 510(k) clearance?

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs received FDA 510(k) clearance on 2024-01-26, under 510(k) number K233598.

Who is the listed applicant for Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs?

The FDA 510(k) record lists Anhui Intco Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs?

The FDA product code for Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs is LZA.

Anhui Intco Medical Products Co., Ltd.를 신청인으로 등재한 기타 기록

K231365니트릴 환자 검사 장갑, 히알루론산으로 칠해져 있으며, 화학요법 약물과 페ンタ니르 사이트레이트와 함께 사용되는 데 대한 검사를 통과, Synguard C+ 니트릴 검사 장갑이라고도 합니다.K191092무분말 비닐 환자 검사 장갑, 노란색 K190095무분말 클리어 비닐 환자 검사 장갑

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